Skip to content
MedsAcross

Medicine

Dexamethasone 20 mg/5 mL injection

Dexamethasone · Intramuscular, intravenous
Available on requestPrescription onlyUS FDAGeneric name

Dexamethasone 20 mg/5 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 2 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store container in carton until contents have been used.

Key facts

Active ingredient (INN)
Dexamethasone
Brand
Sold under the generic name
Strength
20 mg/5 mL
Dosage form
Injection
Route
Intramuscular, intravenous
Packs
25 vials of 5 mL, 5 mL and 1 more
Manufacturers
Fresenius KabiHealthFirst
Origin register
US FDA, United States
Storage
Store container in carton until contents have been used.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
A01AC02 Dexamethasone
HS code (indicative)
3004.32Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
7 September 2000
Identifiers
RxCUI 1116927, 1812194DailyMed set ID 94cb045b-5801-db32-e053-2a95a90a93ef, 2b626a48-c7aa-4443-9164-a08ff069ccd1, 4fedef4f-ec96-4f36-b2f0-01e243e3b89eNDC 51662-1370, 63323-165Application ANDA084916

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
25 vial, multi-dose in 1 tray / 5 mL in 1 vial, multi-dose63323-165-05Fresenius Kabi7 September 2000
25 vial, multi-dose in 1 tray / 5 mL in 1 vial, multi-dose63323-165-26Fresenius Kabi7 September 2000
25 vial, multi-dose in 1 tray / 5 mL in 1 vial, multi-dose63323-165-53Fresenius Kabi17 February 2025
5 mL in 1 vial, multi-dose51662-1370-1HealthFirst13 October 2019
25 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose55150-238-05—1 December 2015
25 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose68083-474-25—4 August 2021
25 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose70121-1451-5—27 August 2018
10 vial in 1 carton / 5 mL in 1 vial0641-6146-10—3 October 2023
25 vial in 1 carton / 5 mL in 1 vial0641-6146-25—15 July 1975
25 vial in 1 carton / 5 mL in 1 vial67457-422-54—11 May 2011
25 vial in 1 carton / 5 mL in 1 vial25021-052-05—1 December 2024
25 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose70069-023-25—8 June 2018
1 vial, multi-dose in 1 bag / 5 mL in 1 vial, multi-dose71872-7128-1—30 March 2018
1 vial in 1 bag / 5 mL in 1 vial71872-7157-1—11 March 2019
1 vial in 1 bag / 5 mL in 1 vial71872-7347-1—21 April 2025
25 vial in 1 carton / 5 mL in 1 vial76420-397-05—31 May 2025
10 vial in 1 carton / 5 mL in 1 vial87063-289-10—7 August 2026
25 vial in 1 carton / 5 mL in 1 vial87063-289-25—7 August 2026
5 mL in 1 vial51662-1297-1—21 July 2019
10 pouch in 1 case / 1 vial in 1 pouch / 5 mL in 1 vial51662-1660-3—15 July 1975
2 vial in 1 carton / 5 mL in 1 vial50090-2313-2—23 February 2016
1 vial in 1 bag / 5 mL in 1 vial0404-9805-05—9 December 2024
5 mL in 1 vial84549-422-54—4 November 2025
25 vial in 1 carton / 5 mL in 1 vial85766-216-25—10 July 2026

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 30 October 1958Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Dexamethasone 20 mg/5 mL injection.

Compare 1

Other strengths and forms of Dexamethasone

Clinical summary

Dexamethasone is a corticosteroid. It is available as tablets, injection and elixir for oral, intramuscular and intravenous use. MedsAcross supplies Dexamethasone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Dexamethasone

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Dexamethasone 20 mg/5 mL injection for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.